To compare the effects of gait training with and without proprioceptive neuromuscular facilitation on balance and gait in chronic stroke patients.
Design
randomized, parallel group trial with double blinded outcome assessment.
Settings and conduct
Data was collected from University Physical Therapy and Rehabilitation Clinic, Lahore Pakistan.
Patients and outcome assessors/data collectors were unaware of group allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria were hemiplegic patients having single episode of ischemic or hemorrhagic stroke diagnosed by neurologist, male and female patients of age between 35 to 85 years, duration of stroke more than 6 months, participants able to walk with or without support for 10 m and participants having Mini-Mental Status Examination [MMSE] ≥24. Exclusion criteria were participants with severe spasticity (modified ashworth scale grade≥3) or severe flaccidity in lower limbs and upper limbs, patients having orthopedic injury that could interfere with walk, patients having visual and auditory impairments.
Intervention groups
In experimental group, Proprioceptive Neuromuscular Facilitation based gait training along with routine physical therapy was performed. Control group received gait training and routine physical therapy. Treatment was provided for six weeks, 3 days per week (on alternative basis) up to six weeks.
Main outcome variables
balance and gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049221N1
Registration date:2020-11-24, 1399/09/04
Registration timing:retrospective
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Momna Asghar
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 56 3785097
Email address
momna2april@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-07, 1398/12/17
Expected recruitment end date
2020-04-25, 1399/02/06
Actual recruitment start date
2020-03-10, 1398/12/20
Actual recruitment end date
2020-07-15, 1399/04/25
Trial completion date
2020-08-26, 1399/06/05
Scientific title
Effects of gait training with and without Proprioceptive Neuromuscular Facilitation on balance and gait in chronic stroke patients.
Public title
Effects of Proprioceptive Neuromuscular Facilitation on balance and gait in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemiplegic patients having single episode of hemorrhagic or ischemic stroke
Participants who are more than 6 months post stroke
Having Mini Mental Status Exam greater than 24
Patients who are able to walk with or without support for 10 m
Patients having no orthopedic injuries
Exclusion criteria:
participants with severe spasticity (modified ashworth scale grade≥3) or severe flaccidity in lower limbs and upper limbs
participants having visual and auditory dysfunctions
Age
From 35 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
randomization was done by lottery method
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and Outcome evaluators were unaware of group allocation.After randomization, study participants were only informed about their allocated exercise program, they remained unaware of the interventions in the other group. Information about the details of both programs was not provided except for similar exercises among both groups. Researchers who assessed outcomes or involved in data analyses will be masked to group allocation.Moreover, if two or more study participants were in the clinic at the same time, they were assigned to different treatment areas without any opportunity to observe each other or their treatment times were rearranged to prevent unintended crossover.
Placebo
Not used
Assignment
Parallel
Other design features
The study is double blinded randomized control trial. two groups are taken, control group and experimental group for comparison
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of The University of Lahore
Street address
207 B block, AWT phase 2, Lahore , Pakistan
City
Lahore
Postal code
75500
Approval date
2020-03-05, 1398/12/15
Ethics committee reference number
IRB-UOL-FAHS/718- IV/2020
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I67
ICD-10 code description
Other cerebrovascular diseases
Primary outcomes
1
Description
balancing capability
Timepoint
before intervention and six weeks after intervention
Method of measurement
Berg Balance Scale
2
Description
Gait parameters
Timepoint
before interventions and six weeks after interventions
Method of measurement
GAITRite platinum
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group in which routine physical therapy was performed for 20 minutes and PNF with gait training for 30 minutes (total 50 minutes session). Routine physical therapy involved muscle strengthening exercises, range of motion exercises and stretching exercises up to patient’s tolerance based gait training involved PNF pelvic patterns, PNF lower extremity D1 Flexion and PNF lower extremity D1 extension, each exercise was repeated 10 to 20 times or up to patient’s tolerance, progressed from rhythmic initiation to stabilizing reversals and then followed by dynamic reversals up to 4th week of treatment session. Other exercises involved pelvic bridging, rolling, sitting and standing exercises and walking practice in parallel bars and treadmill training up to patients tolerance.The treatment was provided at rehabilitation clinic 3 days per week on alternate basis, for 6 weeks (18 sessions). parallel bars, couch, standard chair and treadmill were used during treatment.
Category
Rehabilitation
2
Description
Control group had a treatment session of 40 minutes, 20 minutes of routine physical therapy as that in experimental group that included muscle strengthening exercises, range of motion exercises and stretching exercises up to patient’s tolerance and 20 minutes of gait training alone, that included pelvic rolling, bridging, sitting and standing exercises and walking practice in parallel bars and treadmill training up to patients tolerance. The treatment was provided at rehabilitation clinic 3 days per week on alternate basis, for 6 weeks (18 sessions).parallel bars, couch, standard chair and treadmill were used during treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University Physical Therapy and Rehabilitation center, University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmed
Street address
1 km, Defence road Bhobatian Chowk, Lahore, Pakistan
City
Lahore
Postal code
75500
Phone
+92 56 3785097
Email
momna2april@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Ashfaq Ahmed
Street address
1 km, Defence road Bhobatian Chowk, Lahore ,Pakistan
City
Lahore
Postal code
75500
Phone
+92 56 3785097
Email
momna2april@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr Ashfaq Ahmed
Position
Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 Km, Defence Road Campus,Bhobatian Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
75500
Phone
+92 56 3785097
Email
momna2april@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr Ashfaq Ahmed
Position
Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, Defence road, Bhobatian chowk Lahore, Pakistsn
City
Lahore
Province
Punjab
Postal code
75500
Phone
+92 56 3785097
Email
momna2april@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Momna Asghar
Position
demonstrator
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
207 B block, AWT phase 2, Lahore , Pakistan
City
Lahore
Province
Punjab
Postal code
75500
Phone
+92 56 3785097
Email
momna2april@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effects of gait training with and without proprioceptive neuromuscular facilitation on balance and gait in chronic stroke patients.
When the data will become available and for how long
six months after publication
To whom data/document is available
It will be available to persons involved in patient rehabilitation in academic institutes and clinical settings
Under which criteria data/document could be used
persons involved in patient care
From where data/document is obtainable
communication can be done through emails
What processes are involved for a request to access data/document
data and documents can be shred through email after publication